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  • 1.  Excipient (masking agent) Qualification for drug products

    Posted 25-Jan-2023 14:09
    Hello,

    My company is looking to use a new masking agent for drug product manufacturing.

    We have the ingredient list and some of them are found in IID. However, one of the ingredients is just specified as "Natural Flavor" with no description of which exactly flavor is used. Another ingredient is "Cultured Whey" which also is not in the FDAs IID.
    We also have the statement from supplier saying that all ingredients are either were previously approved by FDA or are FEMA GRAS.

    My question is for the natural flavor and other ingredients that are not in IID, what documents we would need to support the use of GRAS ingredients in pharma product?

    Would the justification for individual ingredients be enough for FDA to not classify masking agent as a novel excipient?

    Thank you,

    ------------------------------
    Valeria
    Canada
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  • 2.  RE: Excipient (masking agent) Qualification for drug products

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jan-2023 09:21
    This message was posted by a user wishing to remain anonymous

    Make sure you ask the vendor to provide a LOA to the DMFs covering these ingredients and submit in the application! Or directly provide composition/process etc in your application!
    Original Message


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